Patient-matched joint filler blocks
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243131544
- Approval date
- August 22, 2024
- Expiry date
- August 21, 2029
- Name
- Tianjin Zhengtian Medical Instrument Co., Ltd.天津正天医疗器械有限公司
- Province/Region
- Tianjin天津
- Address
- No. 318, Jingyi Road, Tianjin Airport Economic Zone天津空港经济区经一路318号
- Production address
- 天津空港经济区经一路318号
The product is bio-fixed with bone or screw-and-bio-fixation, and with joint replacement prosthesis by bone cement, and is suitable for filling periarticular bone defects during revision and replacement of hip and knee joints.
该产品与骨通过生物固定或螺钉和生物固定、与关节置换假体通过骨水泥固定，适用于髋关节和膝关节的翻修置换术中关节周围骨缺损的填充。
The patient-matched joint filling block is made of Ti6Al4V titanium alloy powder material in accordance with ISO 5832-3 by additive manufacturing technology. The product is delivered in a non-sterile state.
患者匹配关节填充块由符合ISO 5832-3规定的Ti6Al4V钛合金粉末材料经增材制造技术制成。产品以非灭菌状态交付。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Patient-matched joint filler blocks in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243131544 and owned by Tianjin Zhengtian Medical Instrument Co., Ltd.. The device was approved on August 22, 2024.
This page provides complete registration details including registrant information, province location (Tianjin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.